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OpenTrials
Completed

NCT Number: NCT02606370

Effects of Unstable Shoes on Trunk Muscle Activity, Lumbar Spine Kinematics and Pain in Patients With Low Back Pain

Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).

Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

About this study

Background: An unstable shoe was developed as a walking device to strengthen the lower extremity muscles and reduce joint loading. A large number of studies have reported increased electromyographic (EMG) activity throughout the gait cycle in most of the lower limb muscles, and significant kinematic changes in the lower extremity. However, no studies have investigated the effects of wearing (1 month) unstable shoes on 1) spine kinematics, 2) trunk muscle activity and 3) Low Back Pain (LBP) during gait in Patients with chronic LBP.

Aim: To compare trunk muscle activity, lumbar spine range of motion (ROM) and LBP during gait using an unstable shoe (Intervention group) and a conventional stable control shoe (Control Group).

Design: Randomized Controlled Trial. Setting: A Biomechanics laboratory. Population: Patients with Low Back Pain.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with Chronic LBP
  • BMI < 30

Exclusion criteria

  • Hernia
  • Lower limb pathologies
  • Previous experience with unstable shoes

Treatment and study plan

Unstable shoe

Other

Wearing Unstable shoes during 1 month

Primary outcomes

  1. Disability (assessed by Roland Morris Questionaire)

    Time frame: At 1 month

Secondary outcomes

  1. EMG activity of trunk muscles

    Time frame: At baseline and at 1 month follow-up

  2. Lumbar spine range of movement (sagittal plane)

    Time frame: At baseline and at 1 month follow-up

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
Sep 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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